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Seminars and Events

Hecker & Associates strongly support professional society, non-profit, and industry efforts to facilitate global teams, train regulatory-oriented medical writers, and improve drug development processes to bring better drugs and biologics to the market faster and less expensively. We serve on multiple program, management, and planning committees for the Drug Information Association (DIA) and the Regulatory Affairs Professionals Society (RAPS) focused on international drug development topics, global submissions, medical writing, regulatory strategy and submission issues, and project management. We serve as mentors to junior professionals, are happy to field questions about or provide regulatory medical writing career advice, and frequently give talks at professional society meetings. These meetings include:

DIA Pharmacovigilance and Risk Management Strategies Conference, Washington, DC, January 23 – 25, 2017

DIA Annual Meeting, San Diego, CA, June 15 – 19, 2014; Judge, for Amgen’s 2nd annual “Regulatory Writing Jeopardy” session

DIA Clinical Forum, Dublin, Ireland, October 7 – 9, 2013; Program Committee member and Co-chair, Medical Writing track

DIA Annual Meeting, Boston, MA, June 23 – 27, 2013: Judge, for Amgen’s “Regulatory Writing Jeopardy” session, and Speaker: “PSUR/PBRER Submission Strategies and Special Requirements in the EU and the US,” in the session “Periodic Reporting in Drug Safety: From Safety Updates to Continuous Safety Monitoring and Benefit-risk Evaluations.”

DIA Annual Meeting, Philadelphia, PA, June 24 – 28, 2012; Session Organizer: “Efficient Regulatory Medical Writing for Global Submissions Including “ICH Outlier” Authorities,” and Speaker: “A Writer’s Perspective on Safety Documents Before the Marketing Application,” in the session “Wrangling the Bestiary of Safety Documents: Coordination and Integration Across Multiple Requirements.”

DIA Clinical Forum 2011, Basel, Switzerland; Cross Functional Working for Better Results, October 10 – 12, 2011; Speaker: “US Agent-Appropriate Writing” in the session “European Sponsor Success with FDA.”

DIA Annual Meeting, Chicago, IL, June 19 – 23, 2011; Session chair “Constructing Key Clinical Documents for Global Use.”

DIA Annual Meeting, Washington, DC, June 13 – 17, 2010; Session chair and Speaker: “Medical Writing for Global yet Harmonized CTA Submissions,” in the session “INDs with a Global Focus,” and “Safety Report Considerations in Clinical Trials: What to Do and What not to Do,” in the session: “Reporting Safety Data in FDA Marketing Applications: Is There a Change in FDA Expectations?”

RAPS eCTD Advanced Workshop, Rockville, MD, April 19 – 21, 2010; Speaker: “Safety (Nonclinical) Content Overview.”

exl pharma, 2nd Leveraging Global eCTD Efficiencies; eCTD Submission Management & Standards for a Global Regulatory Landscape, Washington, DC, January 11 – 12, 2010; Speaker: “Document Granularity for Existing Products.”

DIA Clinical Forum, Nice, France, October 19 – 21, 2009; Speaker: “Writing the Development Safety Update Report (E2F): What You Need to Know” in the session: “Best Medical Writing Practices in the Outsourcing of Aggregate Safety Reports.”

DIA Annual Meeting, San Diego, CA, June 21 – 25, 2009; Session chair and Speaker: “Deciding Placement for IND Foreign Clinical Data to Facilitate Strategic Lifecycle Maintenance” in the session: “IND to CTD in Electronic Format: Strategic Considerations for Lifecycle Maintenance.”

DIA Annual Conference for Electronic Document Management, Philadelphia, PA, February 11-13, 2009; (speaker): “Deciding Strategic Placement for IND Foreign Clinical Data to Facilitate Lifecycle Maintenance.”

DIA Annual Meeting, Boston, MA, June 22-26, 2008; Speaker in the session: “Best Practices for Acting as a US Agent.”

DIA Clinical Forum 2007; Global Trends in Medical Writing and the Evolving Regulatory Environment, Madrid, Spain, October 17-19, 2008; Program Committee and Session Chair “Electronic Clinical Trial Application Best Practices.”

DIA Annual Meeting, Atlanta, GA, June 17-21, 2007; Speaker and Session chair: “Tailoring the IB to IMP Development Status and Region” in the session: “The Evolving Role of the Investigator Brochure in Global Submissions” and Speaker: “Submitting an IND in eCTD Format to CDER: Determining Appropriate Placement of Clinical Information” in the session: “Submitting an IND in eCTD Format: Lessons Learned.”

DIA Annual Conference for Electronic Document Management, Philadelphia, PA, February 6-9, 2007; Speaker and Tutorial Chair: “Placing the Clinical IND Sections in the eCTD Format” in the tutorial: “Writing the CTD – Learning from Best Practices” and Panelist in the Post-conference Workshop: “Are We Providing Useful Summary Documents?”

DIA Annual Meeting, Philadelphia, PA, June 18-22, 2006; Session chair and Speaker: “Achieving an Effective Process Quickly, Without Sacrificing Quality” in the session: “Review and Outsourcing Strategies.”

DIA Annual Conference for Electronic Document Management, Philadelphia, PA, February 7-10, 2006; Speaker: “Adapting the IB for the Development Life Cycle” in the session: “Burning Issues in Medical Writing: Ask the Experts Panel.”

DIA Annual Workshop on Medical Writing, Washington, DC, October 24-25, 2005; Session chair and Speaker: “Protocol Considerations to Meet CTA Requirements in Canada, the EU, Japan, and the US Simultaneously” in the session: Global Clinical Trial Applications and (speaker) “Writing Clinical Submission Documents for Europe (Particularly if You’re Not European)” in the session: The CTD: Writing for the Medical Reviewer.

DIA Annual Meeting, Washington, DC, June 26 – 30, 2005; Speaker: “The Art of Writing Safety Narratives” in the session: “Discovering and Reporting Safety Issues in Clinical Trial Data.”

RAPS 2004 Annual Conference & Exhibition, Washington, DC, October 10-13, 2004; Speaker: “Overview of EU Medical Product Legislation, Medicinals: Background and Organisation,” “Medicinal Products, Clinical Trials,” and “Medicinal Products: Post Marketing Requirements” at the preconference meeting “An Overview of EU Regulatory Requirements for Medicinal Products and Devices.”

RAPS Principles and Practices of EU Regulatory Affairs, Arlington, VA, September 13-14, 2004; Speaker: “Overview of EU Drug/Biologic Legislation” and “Post-Marketing Responsibilities of the Marketing Authorisation Holder.”

DIA Annual Meeting, Washington, DC, June 13-17, 2004: Speaker: “If the New Format Fits, Share It: Options for Fitting the ISS and ISE Analyses into the CTD Format.”

DIA EuroMeeting, Prague, Czech Republic, March 10-12, 2004: Speaker: “Is the CTD Format Usable for Clinical Trial Applications?” in the Session: European Directive on Clinical Trials, Current Implementation Status in the 15 Member States and in the Industry.

RAPS Principles and Practices of EU Regulatory Affairs, Arlington, VA, February 23-24, 2004; Speaker: “Overview of EU Drug/Biologic Legislation,” “Marketing Applications/CTD,” and “Overview of Clinical Trials.”

DIA European Workshop on Medical Writing, Paris, France, February 12-13, 2004; Speaker “Fitting a Clinical Trial Application into the CTD format, Cinderella’s Glass Slipper.”

DIA Practical Implementation of the Common Technical Document (CTD), Arlington, VA, December 8-9, 2003; Speaker: “If the New (Format) Fits, Share It: Options for Fitting the ISS and ISE Analyses into the CTD Format.”

RAPS 2003 Annual Conference & Exhibition, Baltimore, MD, October 19-22, 2003; Session Chair and Speaker: “The Common Technical Document: Where Have We Been and Where Are We Going?”

DIA 39th Annual Meeting, San Antonio, TX, June 15-19, 2003; Speaker: “Regulatory Submissions–Requirements for Successful Medical Writing.”

DIA 4th Annual Workshop in Japan for Medical Writing, Tokyo, Japan, May 15-16, 2003; Speaker: “Submission Strategies: US and Europe.”

Barnett International, Implementing the Common Technical Document. Hands-on Strategies for Practical Implementation and Compliance, Philadelphia, PA, April 2-4, 2003; Speaker: “CTD Basics: Regional Considerations for Global Success.”

RAPS Education Program, Alexandria, VA, March 17-18, 2003; Program Chair, Session Chair, and Speaker: “Submission Strategies and Review Processes.”

DIA Medical and Technical Writing Workshop, Baltimore, MD, October 21-22, 2002; Program Committee, Session Chair and Speaker: “Presentation of Documents: Industry and FDA Perspective.”

RAPS 2002 Annual Conference, Washington, DC, October 6-9, 2002; Session Chair and Speaker: “So You Want to be a Consultant…?” and Session Chair and Speaker: “EU Legislative Update” (a review of the current status of important initiatives such as EU Directive 2001/20/EC, the clinical trials directive).

DIA Annual Meeting, Chicago, IL, June 16-20, 2002; Session Chair and Speaker: “Style, You Either Have it or You Don’t: Style Guides and Standard Formats.”

RAPS 2002 European Annual Conference, Budapest, Hungary, May 7-9, 2002; Program Committee and Speaker: “Writing and Review Processes to Ensure Regulatory Submission Quality” and “PSURs: Global Considerations for New and Old Products.”

RAPS RA/QA 101 An Introductory Regulatory and Compliance Workshop, Arlington, VA, April 25-26, 2002; Program Committee and Speaker “The Product Development Pipeline,” “Marketing and Post-Approval Regulatory Processes,” “Global Perspectives,” and “Career Ladders.”

DIA Workshop: Practical Implementation of the Common Technical Document (CTD), Arlington, VA, April 22-23, 2002; Speaker: “Facilitating Global Team Creation of the Clinical Sections of a CTD.”

Gardner Carton & Douglas, Biotech and Healthcare Industries Strategies for Success 2001-2002 Seminar Series, Clinical Trials–Biotech and Healthcare Compliance Issues, Washington, DC, February 27, 2002; Speaker: “Compliance Issues to Consider When Establishing a Clinical Trial.”

RAPS Global Awareness: European Drugs and Biologics, Alexandria, VA, January 15-16, 2002; Program Committee and Speaker “Considerations and Regulations for Clinical Trials of Drugs and Biologics.”

RAPS ICH Progress, Alexandria, VA, January 14, 2002; Program Committee Chair and Speaker “The Clinical Trial Report Guideline (E3) Six Years On: Progress and Its Role in the US, EU and CTD.”

RAPS 2001 Annual Meeting, Baltimore, MD, November 4-7, 2001; ICH Session Chair and Speaker “The Clinical Trial Report Guideline (E3) Six Years On: Progress and Its Role in the US, EU, and CTD.”

DIA Medical and Technical Writing Meeting, Vienna, Austria, October 11-12, 2001; “Creating an Author – Medical Writer Team: Practical Tips” and “Team Creation of Timely High Quality Clinical Trial and Marketing Applications.”
DIA Annual Meeting, Denver, CO, July 8-12, 2001; “Insights into Producing Timely, High Quality Marketing Applications–a Sponsor-CRO Dialog.”

DIA Medical and Technical Writing Meeting, Baltimore, MD, October 5-6, 2000; “Successful Clinical Trial and Marketing Applications Writing.”

DIA Annual Meeting, San Diego, CA, June 11-15, 2000; CRO/Sponsor Writing Partnership: “Keys to Successful Team Writing of Applications.”

DIA, Survival Skills for Medical Writers, Dublin, Ireland, October 7-8, 1999; CRO/Sponsor Writing Partnership: “You Want It When?”